Ultrafiltration (Aquapheresis) in the Management of Patients With Leukemia and Severe Fluid Overload
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- M.D. Anderson Cancer Center
- Primary Endpoint
- Safety and Efficacy of Aquapheresis versus Diuretic Therapy
Study Overview
Brief Summary
The goal of this clinical research study is to learn about the safety and level of effectiveness of aquapheresis compared to diuretic drugs. Diuretic drugs are designed to help the kidneys to form more urine. They also remove fluids from patients with severe fluid overload who have not responded to diuretics.
Aquapheresis is a procedure that removes excess fluid from the body. Blood containing too much salt and water is withdrawn from the body using catheters (sterile flexible tubes) and passed through a special filter. The filter separates the excess salt and water from the blood. The blood is returned to the patient and the fluid is collected in a bag to be disposed. Aquapherisis may benefit patients by removing excess fluid and salt from the body.
Detailed Description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. The first group of 10 participants to join the study will be enrolled in the Pilot portion of the study. The next group of up to 40 participants will be enrolled in the Randomized portion of the study.
In the Pilot portion of the study, researchers want to learn about the safety and level of effectiveness of aquapheresis in leukemia patients with severe fluid overload who do not respond to diuretics.
If you are in the Randomized portion of the study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to each group.
- Group A will receive aquapheresis.
- Group B will receive furosemide. The doctor will discuss this with you.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients must be 18 years of age or older and have a diagnosis of leukemia and be hospitalized on leukemia floor or MICU
- •Weight gain of 10 pounds or more.
- •In addition, patients should have 2 or more signs and symptoms of fluid overload such as: dyspnea, orthopnea, paroxysmal nocturnal dyspnea (PND), peripheral edema, rales, jugular venous distension (JVD), hypoxia (pulse ox < 90% on room air) and pulmonary edema by chest X-ray.
- •AND be poorly responsive to diuretics defined as positive fluid balance or < 1% decrease in current body weight / 24 hours with use of furosemide 60 mg IV/24h.
- •Subjects will be eligible regardless of poor performance, organ dysfunctions, organ failures, or other criteria of decompensation and/or debilitation.
- •Subjects will be eligible regardless of platelet counts.
- •Patients may be on a regular floor or in the intensive care unit.
- •They may be on respiratory mechanical ventilation or not.
Exclusion Criteria
- •Indication for dialysis (as judged necessary by nephrology (hyperkalemia, acidosis).
- •AKI defined as 100% increase in baseline creatinine.
- •Hypotension (SBP < 90mmHg).
- •Pregnant or breastfeeding women are excluded.
Arms & Interventions
Pilot Phase Aquapheresis
The first portion of this study is an open label pilot experience to evaluate the safety of aquapheresis in leukemia patients with severe fluid overload non-responsive to diuretics. A total of 10 patients will be treated.
Intervention: Aquapheresis (Procedure)
Aquapheresis
Participant connected to aquapheresis pump through an intravenous (IV) catheter placed in forearm. About 6 teaspoons of blood will flow through the blood circuit, and the excess fluid will slowly be collected in the collection bag. The exact length of time of aquapheresis treatment is determined by how much fluid needs to be removed and how fast it can be removed. The average treatment is about 24 hours but can extend up to 7 days. About 6 liters or 13 pounds will be removed.
Intervention: Aquapheresis (Procedure)
Diuretics
Furosemide by vein over about 15 minutes every 8 hours or by vein as a continuous (non-stop) infusion.
Intervention: Furosemide (Drug)
Outcomes
Primary Outcomes
Safety and Efficacy of Aquapheresis versus Diuretic Therapy
Time Frame: 72 hours
Primary end point is success rate defined as achievement of weight loss of 7 pounds or 50% of weight gain, whichever is greater without \>/=100% increase of baseline creatinine at 72 hours.
Secondary Outcomes
- Complete Response(72 hours)